Orthopedic Associates of Duchess County
BoneScalpel has transformed the way I approach the spine and perform complex procedures. This tool allows for the precise removal of large, geometric pieces of bone while protecting the neural elements. BoneScalpel’s ability to make such precise cuts, while sparing the surrounding soft tissue are characteristics stark in contrast to traditional spinal decompression instruments that are sharp, aggressive, and spin with high speed. Such instruments include kerrisions, chisels/gaughes, and high speed burrs. I have found that my laminectomy procedures are much faster and associated with significantly less bleeding and durotomy risk through the use of BoneScalpel.
For use in multilevel laminectomy procedures I start by making bilateral, medially directed BoneScalpel cuts at the spinolaminar lines to allow en bloc removal of the central lamina. Once the central canal is safely exposed, I probe the neural elements, lyse adhesions, and place protective cottonoid paddies in the lateral recesses. I then perform bilateral, laterally directed BoneScalpel cuts to decompress the lateral recesses and foramina. Furthermore, the value in using this tool to perform cervical laminectomies is incredible. Such procedures are often bloody, time consuming and risky. BoneScalpel cuts the surgical time on these cases in half.
Hospital Angeles Lindavista
By means of this letter I would like to share my experience with the use of the [BoneScalpel] ultrasonic scalpel in surgeries of the spine and occipital bone undertaken at the National Medical Center La Raza during 2014 and 2015. I have operated on approximately 50 patients for spine tumors via laminoplasty at the cervical, thoracic, lumbar and sacral levels, as well as surgery for decompression, corpectomies, and ventral osteophytes, including two cases involving craniotomies at the cervical level. The use of BoneScalpel has in my experience reduced the time of surgery, and minimized bone loss from one to seven levels, preserving the patient’s anatomical integrity and maintaining adequate ligament function. Another important advantage is safety obtained from keeping soft tissue (arteries, veins and never tissue) free of damage, and finally, this achieved with minimal bleeding. I consider the BoneScalpel to be an innovative, practical, safe and reliable tool for spinal surgeries.
Angeles Del Pedregal Hospital & Siglo XXI National Specialized Medical Center
By means of this letter I would like to express the importance that the BoneScalpel ultrasonic (ultrasonic bone cutter) has represented to my institutional and private practice, which I use for tumor, degenerative and trauma spine surgery. I have realized excellent results and benefits thanks to the clean cuts with minimal bleeding, and protection of the neural and vascular tissue, while reducing the surgical time. In the past I utilized drills and hand instruments for radicular and medullary decompressions which presented inherent risks to neural structures. I would like to thank you for bringing this technology to Mexico which benefits both patients and spine surgeons alike, and additionally I feel important to mention the added value you provide with your excellent service and support to ensure adequate equipment function.
The BoneScalpel is the best new tool for spinal surgery in the last 15 years.
St George’s University Hospital
The Misonix bone scalpel is a great tool for cutting bone adjacent to sensitive neural tissue. I have found it greatly enhances safety and speed whilst reducing blood loss in both deformity surgery and spinal tumour resection. As a bonus, it doesn’t turn good local bone graft into powder like a high speed drill does. If you are used to an osteotome and have used a plaster saw in the past, then it is very intuitive to pick up and use.
Fellow: Royal College of Surgeons (Orthopaedics) – 2001
Fellow: Royal College of Surgeons (Edinburgh) – 1994
Winner: G.B.Ong medal for FRCS (Edinburgh) examination
Cedars-Sinai Medical Center
Cedars-Sinai Medical Center
I have been using the Misonix BoneScalpel for multi-level laminectomies and have found that it is a very precise tool for bone-cutting and bone-shaving that gives me control and provides safety around delicate soft tissue structures.
Additionally, I think it is very impressive that there is a significant reduction of bleeding in the bone when I use this device to make my cuts. This technology has become a part of my standard of care for osteotomies.
Our success in healing wounds can be attributed to the addition of the use of this innovative device in our facility. The ability to select from a variety of specialty tips allows us to address all wound shapes and sizes. We have been able to easily excise tissue and remove necrotic tissue, establishing a clean wound bed. In the past we would have used a scalpel, but now we can achieve better results with the added benefits of low frequency ultrasound which include less bleeding and bacteria control. In the case below, the patient had a large open wound with exposed tendon. The decision was made to send the patient to the OR for debridement using the SonicOne technology. During surgery, all of the necrotic tissue was easily removed, resulting in a clean wound bed. Immediately after the debridement a bioengineered skin substitute was easily applied. With continued care, the patient’s wound is on track to successfully heal.
Frank Aviles, PT, CWS, WCC, FACCWS, CLT
NEW YORK COMMUNITY HOSPITAL
In many cases, when standard wound care does not produce the desired level of improvement, surgical debridement is required. The use of ultrasonic surgical debridement is an excellent option. It allows me to be very aggressive in the removal of non viable tissue within the wound bed. It also allows me to remove healthy tissue, as required, with minimal bleeding. Net result, a clean wound bed which is critical for many post debridement procedures, such as the application of a skin graft.
In the case below, the use of ultrasonic debridement was our last hope to save this patient’s foot. The use of ultrasound allowed me to be very controlled and precise during the debridement procedure, resulting in an incredible debridement which allowed me to apply a skin graft immediately post surgical debridement.
ERIE COUNTY MEDICAL CENTER
As a podiatrist and wound physician at the Center for Wound Care & Hyperbaric Medicine at The Erie County Medical Center, a level one trauma center in Buffalo, NY, I frequently encounter wounds that require surgical debridement. One of my frustrations historically with the older hydro-therapy based technology that we once used, has been the difficulty in removing the necrotic tissue without sacrificing viable structures. Unlike the non-selective waterjet technologies for debridement, SonicOne is very selective and specific to different tissue types which means that we can now more safely debride away unhealthy and non-viable tissue while at the same time preserve vital structures and healthy tissue.
I have been using SonicOne for several months and am beyond pleased with its efficacy. SonicOne is ten steps above anything I have ever used for surgical debridement as it decreases operating time, does not damage healthy tissue, can effectively treat biofilms, and it seems to be less expensive than traditional methods of non-scalpel, sharp debridement.
Center for Wound Care and Hyperbaric Medicine — Erie County Medical Center
Assistant Clinical Professor in the Department of Orthopaedics — University at Buffalo School of Medicine and Biomedical Sciences
Chief of the Podiatry Section of the Department of Orthopaedics — Kaleida Health System
Sports Medicine Institute — State University of New York at Buffalo
ST. LUKE’S HOSPITAL SYSTEM
I have had over 30 years of experience in wound care at several university hospitals and wound centers and have used multiple techniques for wound debridement. Our clinical goal is to achieve specificity by removing, selectively, only tissues that are nonviable and to carry this out in an expeditious and in as non-hemorrhagic way as possible.
Our six month experience with the Misonix SonicOne OR has been most impressive. Clearly, it has specificity in removing only those tissues that appeared to be nonviable. It was very efficient in our experience with nearly 40 patients.
Finally, because of its precision, we were able to achieve wound closure much quicker utilizing this instrument over others. In addition, this method of debridement proved to be time efficient with minimal tissue trauma and blood loss. Faster healing and less time in the OR helps my patients’ outcomes and also reduces costs for the hospital. I recommend the SonicOne OR to any wound practitioner as it is clearly a superior instrument over its predecessors.
University of Kansas School of Medicine — Clinical Professor
University of Virginia School of Medicine — Clinical Professor
SAINT BARNABAS MEDICAL CENTER
As a burn surgeon in an American Burn Association verified burn center, I have extensive experience in treating patients with third degree burns which require skin grafting. I have been using the SonicOne on third degree burns for about six months. It is great for debriding and excising granulation tissue and third degree areas with fine coagulum.
Compared with standard excision, SonicOne excision seems to have less blood loss, and lower transfusion requirements. It also improves operating time due to less time for hemostasis. Since the debridement tool has no blade, there is no chance for sharps injury in the operating room. Different debriding tools also allows for precise excision around delicate areas such as the face and hands.
Abraham Houng, MD FACS
Division of Burn Surgery
CLARA MAASS MEDICAL CENTER- BARNABAS HEALTH
It’s rare that I offer a letter of testimony for any new piece of medical equipment, but the SonicOne O.R. system from Misonix is one that I feel compelled to offer my complete endorsement. Six months ago, Barnabas Health of New Jersey, made an institutional change from an older wound debridement technology to the newer SonicOne O.R. system. Given my extensive clinical experience with the outgoing technology, my hospital administration had asked that I provide a rigorous evaluation of the Misonix system to assess whether it represented a significant enough advancement in surgical debridement to justify this institutional change over. With only having using the SonicOne O.R. for one day, it was absolutely clear that this was going to be a seismic change in the way we treat wounds going forward and, very soon after that, Barnabas Health brought the systems into our operating rooms. Unique to the ultrasonic SonicOne O.R. system is the tissue specific nature of the debridement; it removes necrotic tissue, but knows to leave the healthy tissue undisturbed. This makes it not only more effective, but also safer for vital structures like nerves, vessels and tendons which frequently get sacrificed with alternative methods of debridement. Of additional benefit is the cavitation effect from the ultrasound and its ability to provide an antibacterial effect, which can kill biofilms. Anything that can assist in decreasing biofilms will have immediate implications in the number of serial debridements requires to heal wounds and this is really an important improvement both clinically and economically. Lastly, and perhaps most unique, is the system’s ability to not only debride soft tissue, but it has a series of hard tissue (bone) cutting elements that allow us to do a complete procedure with the system (hard and soft tissue) that we simply couldn’t do in the past with the older technology. This makes my time in the operating room more efficient and allows me to see more patients.
In summary, the SonicOne O.R. represents the most important advancement in wound debridement technologies, for the operating room, in recent years. In fact, we were so impressed with the SonicOne O.R., that we brought a sister product, SonicOne Plus, into our outpatient Wound Center as well. This is going to really make a difference in the efficiency in our clinical protocols and ultimately in the outcomes of our patients. My colleagues and I couldn’t be more impressed with how well this device has performed. It has exceeded all expectations and I anticipate this fast becoming a new standard of care.
Wayne Caputo, DPM
REID HOSPITAL & HEALTH CARE SERVICES
Of all the new technologies that have been introduced in the past ten years in spine surgery, the Misonix BoneScalpel stands out as the one that has perhaps had the most positive impact in the operating room. The BoneScalpel has significantly shortened surgical procedure time, reduced blood loss, reduced incidence of dural tears and obviated the need for allograft bone graft for spinal fusions. Highly recommend this product.
Ravishankar Vedantam, MD
CANTOR SPINE INSTITUTE
I have not performed a traditional laminectomy in almost two years and the Misonix BoneScalpel has been the game-changer. My practice focuses primarily on motion sparing and minimally invasive spine surgeries and this tool has facilitated advances previously not possible or safe. After more than 20 years of clinical practice, this technology has enabled me to design new surgical techniques that are truly much less invasive.
The BoneScalpel ultrasonic osteotome enables surgeons to isolate, and essentially dissolve, nerve-compressing lesions. A precision sculpting tool that allows safe bone cutting in a tiny space, this instrument allows access to work inside the spinal canal with less compromise of native anatomy. In my practice, traditional tools have become an adjunct to the BoneScalpel.
There is a necessary learning curve when using this tool for these more delicate applications. I have invested many hours working in a cadaver lab to perfect the technique. Time well-spent, because it has changed the way I do spine surgery. As a result of this much less invasive approach, there are multiple clear advantages for patients: safe access through a smaller incision with equal or better decompression, less post-operative pain, shorter hospital stay, less blood loss, less blood product transfusions, fewer dural tears, shorter recovery, preservation of spinal anatomy and structure resulting in fewer fusions, fewer implants, and more cost effective.
Jeffrey B. Cantor, MD, FAAOS
METHODIST HOSPITAL HOUSTON
As a practicing neurosurgeon at Methodist Hospital Houston, I view the Misonix BoneScalpel as one of the three most important technologies to enter the spine world in the last 10 years. It has been of tremendous value to my practice particularly in adult deformity surgery where multiple laminectomies and Smith-Peterson osteotomies are needed. The BoneScalpel’s precision and coagulative effect facilitate safety and efficiency in both simple and complex procedures. In major deformity correction surgeries, such as Pedicle Subtraction Osteotomies, the bone scalpel has helped minimize blood loss and decrease the need for blood transfusion. Use of the BoneScalpel also allows for removal of bone in largery pieces which can be used locally to enhance spinal fusion.
The BoneScalpel has joined other cutting edge technologies that help our institution to maintain its leadership position and provide the best clinical outcomes for our patients.
Paul Holman, MD
TEXAS BACK INSTITUTE
The ultrasonic osteotome or Misonix BoneScalpel has been a very valuable addition to my surgical tools. I perform many complex spinal procedures and the BoneScalpel has allowed me to be more precise and more efficient with bone cutting and bone removal. It’s main advantage relates to the limited collateral tissue damage. I no longer worry about using a high speed burr and tearing dura (the lining of the spinal cord) or wrapping up nerves.
Over the past two years I have completely moved away from other mechanical devices such as mallets, osteotomes or drills as the ultrasonic tool offers precision and efficiency without the risk of precussing the spinal cord or nerves. As a result of the more efficient surgery I am able to perform multilevel decompressions in half the time than was expected or customary. As such I now routinely schedule surgeries for a shorter time frame than in the past. In addition by virtue of its mechanism of bone cutting it self-seals the venous bone channels so there is far less bleeding.
I experienced the real value of the BoneScalpel with my recent trip to Uganda. I organize a charitable spine surgery mission and Misonix generously donated a unit for use during the mission. Under the most severe surgical conditions the BoneScalpel allowed me to perform the most complex of surgeries without any issues. As less blood is lost with its use, it helped to maintain the patient’s fluid balance which greatly helped the local anesthesiologist in coping with some very complex procedures. It also minimized the need for blood transfusions which were much harder to come by and would have come at a higher risk for complications or disease transmission.
The BoneScalpel has changed the way I perform and teach spine surgery.
Isador Lieberman, MD, MBA, FRCSC
RADY CHILDREN’S HOSPITAL
The ultrasonic BoneScalpel allows me to perform precise bone cuts in the spine safely and efficiently without having to hit on an osteotome close to the spinal cord, and I was pleasantly surprised by the amount of reduced blood loss in my spinal deformity surgeries as compared to using traditional mechanical bone cutting instruments.
I had suspected the ultrasonic BoneScalpel contributes to a reduction in bone bleeding and thus a reduced need for blood transfusions and cell salvage use, and the results of this study convincingly confirmed this when I compared 20 surgeries with BoneScalpel against two control groups based on my previous surgical experience.
Peter Newton, MD
As a neurosurgeon specializing in spinal microsurgery, I have had extensive experience with the use of BoneScalpel in spine surgery and find it to be a safe and effective ultrasonic bone dissector that, in my opinion, will soon become an integral part of the armamentarium of every well-trained spine surgeon.
The routine use of BoneScalpel has the potential to produce significant cost savings. The ability to harvest autologous bone en bloc during laminectomies and facetectomies and utilize that bone for fusion has significantly reduced our reliance on expensive fusion supplements such as recombinant bone morphogenic protein (BMP) and implanted bone stimulators. The reduction in bleeding during multilevel laminectomies has reduced the use of cell savers and the rate of blood transfusions.
Most importantly, the reduced risk of cerebrospinal fluid leak and neurological injury is expected to have significant economic beneifts, such as reduced use of tissue sealants, diminished length of hospital stay, and reduced rate of readmissions and reoperations for CSF complications. Increasingly, pay-for-performance insurance models levy penalties for “avoidable” complications such as urinary catheter and intravascular line infections. It may not be long before payment is denied for readmissions or prolongations of stay due to iatrogenic surgical complications such as cerebrospinal fluid leaks.
I believe BoneScalpel is as significant to spine surgery today as the adoption of pneumatic drill was several decades ago.
Peyman Pakzaban, MD, FAANS
BoneScalpel is one of the most important advancements in spine surgery during the last few years and it will become a preferred surgical tool for the next decade and beyond.
SHRINERS HOSPITALS FOR CHILDREN – PHILADELPHIA
I have found the bone scalpel very useful during my scoliosis surgeries. Whereas before I was mostly banging on an osteotome near the spinal cord to perform facetectomies and osteotomies, now I can perform precise safe cuts with the bone scalpel. The surgeries are safer, particularly when work around the dura is required, and more efficient. As I have gained more confidence in the scalpel, I am able to work more efficiently with less blood loss. The blood loss factor is particularly apparent when performing three column osteotomies. The bone bleeds less, surgeon spends less time attaining hemostasis, which in turn leads to a faster and safer operation.
NEMOURS / ALFRED I. DUPONT HOSPITAL FOR CHILDREN
The BoneScalpel has improved operative efficiency and blood loss in complex pediatric spinal deformity surgery at our institution. Within the first few cases we recognized that this tool has tremendous value in spine surgery. It has now become my routine to use the BoneScalpel for every deformity case; and it is useful for multiple steps in the procedure. Facetectomy with the bone scalpel is easy, quick, harvests local bone graft and seals cancellous bleeding so the resected facet is not bleeding for the whole case. Ponte osteotomies have become efficient and virtually effortless as the BoneScalpel resects the pars and remainder of the articular facet, creating apical flexibility in curves without damaging the epidural veins, exiting nerve root or adjacent dura. Furthermore, when used for bone removal/cutting in vertebral column resections, rib osteotomies or thoracoplasty, the ultrasonic technology performs the meticulous work safely and efficiently, while minimizing bleeding and soft tissue trauma.
Suken Shah, MD
NEW ENGLAND BAPTIST HOSPITAL
The general advantages of the BoneScalpel are numerous. We now use it essentially on every spine patient, and we have found in our practice that it significantly reduces operative time, decreases blood loss, and markedly increases the amount of residual local bone available for grafting. In so doing, it significantly reduces overall O.R. time and O.R. cost.
With an osteotomy, we used to assess whether to do one, two or even three osteotomies with a complex deformity. It gives you pause when you know that each osteotomy is going to add 20 to 30 or even 40 minutes of operative time, as well as the increased blood loss and the increased potential risk. But now with the BoneScalpel, we can finish in a matter of 2 minutes, essentially bloodlessly, and it significantly improves the ability to vary our approach in a controlled fashion to achieve and perform a correction.
Eric Woodard, MD